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Biosimilar Barricade Breached: Amgen Manufacturing Patents Ruled Not Infringed

 
• By Brenda Sandburg

Apotex's Neulasta and Neupogen biosimilars do not infringe Amgen's patent, showing sponsors can get around innovator's manufacturing process patents.

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Apotex Inc. has eliminated a legal roadblock to launching its biosimilars to Amgen Inc.'s Neulasta (pegfilgrastim) and Neupogen (filgrastim) but still has to convince FDA to clear its applications.

Judge James Cohn of the US District Court for the Southern District of Florida ruled that Apotex's biosimilar candidates do...

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More from Biosimilars

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.